Post on 16-Jan-2016
description
“Independent Medical Education Support from Genentech
Provider Training”
The webinar will begin shortly.
If you need technical assistance please email us at acme@commpartners.com
You may also send us a message via the questions/chat box in the lower left-hand corner of your screen.
2
““Independent Medical Education Independent Medical Education Support from GenentechSupport from Genentech
Provider Training”Provider Training”September 6, 2007 at 2:00 PM ET, 1:00 PM CT, 12:00 PM MT, 11:00 AM PT September 6, 2007 at 2:00 PM ET, 1:00 PM CT, 12:00 PM MT, 11:00 AM PT
Trudi BloomMedical Education Grants Manager
Gisela PaulsenDirector, Independent Medical Education Department
3
Please take a moment to answer the poll Please take a moment to answer the poll questions below.questions below.
How many people are participating in this webinar at your location today?
1234567
8 or more
4
Please take a moment to answer the poll Please take a moment to answer the poll questions below.questions below.
What is your provider type? Hospitals/Health Systems
Medical Schools
Medical Specialty Societies
State Specialty Societies Commercial Supporter
Federal Health Care Educators
Health Care Education
Associations
Medical Education and
Communication Company
Other
Have you ever requested a grant from Genentech for independent medical education?
Yes
No
5
AgendaAgenda
• What is the Independent Medical Education Department (IMED)?
• What is the process for requesting independent medical education grant funding from Genentech?
• What tools and resources are available to me?
• Q & A
6
AgendaAgenda
• What is the Independent Medical Education Department (IMED)?
• What is the process for requesting independent medical education grant funding from Genentech?
• What tools and resources are available to me?
• Q & A
7
IMED Vision, Mission, and GoalsIMED Vision, Mission, and Goals
GoalsGoals
MissionMission
VisionVision
Encourage and support the evolution of quality independent medical education while ensuring alignment with ACCME, AMA, PhRMA Code, OIG, and FDA guidance.
Ensure that grant applications are received, handled, reviewed, and evaluated according to the highest standards and in full compliance with applicable laws, regulations, and guidelines.
Manage Genentech’s continued commitment to supporting quality independent medical education that improves patient care.
8
Genentech’s IndependenceGenentech’s Independence
Note: Genentech personnel may not in any way assist with or facilitate grant requests during any phase of the request, nor can they forward grant requests to IMED on behalf of a provider.
Genentech Genentech will will NOT:NOT:
Genentech Genentech will will NOT:NOT:
Influence the development of
educational content
Influence the development of
educational content
Select educational methods or venueSelect educational methods or venue
Influence selection of presenters
and/or moderators
Influence selection of presenters
and/or moderators
Define educational needs or objectives
for an activity
Define educational needs or objectives
for an activity
Influence selection of persons “who will be in
a position of control over the content”
Influence selection of persons “who will be in
a position of control over the content”
9
AgendaAgenda
• What is IMED?
• What is the process for requesting What is the process for requesting independent medical education independent medical education grant funding from Genentech?grant funding from Genentech?
• What tools and resources are available to me?
• Q & A
10
Medical Education Grant ProcessMedical Education Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
Providers must ensure that grant requests meet IMED criteria
Grant requests must be submitted via www.imed.gene.com
Requests must be submitted no less than 60 calendar days prior to the planned activity start date or the date the requestor requires a decision (whichever is earlier)
IMED will review requests to ensure that activities are compliant, fair-balanced, scientifically rigorous, and unbiased
The review process can take up to 60 calendar days
IMED provides limited optional activity assistance upon request
IMED may require providers to submit monthly status updates on activity execution
5 6
Grant Decision
Reconciliation
IMED will approve or deny the grant request
Providers will be notified of the grant decision via e-mail
IMED will require reconciliation reports within 90 days of the end date
11
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
Medical Education Grant ProcessMedical Education Grant Process
12
Grant EligibilityGrant EligibilityCharitable and Charitable and
Patient ProgramsPatient Programs
IMEDIMED
Research and Research and DevelopmentDevelopment
Other SupportOther Support
For information on all types of grant requests considered by Genentech, please visit the all-grants portal at www.grants.gene.com.
Community and Charitable Activities Patient Advocacy Education Not for HCPs Medical Foundation Support
Independent Medical Education (Live and Enduring) Professional Society and Association Educational Support Live Educational Activities Print, Recorded, and Interactive, Computer-Based Programs Travel Grants for Healthcare Professionals in Training
Research and Development Fellowships Other Third-Party Awards to Fellows Institutional Grants to Fund Research
Medical Association-Initiated Fellowship Trade Society/Association Requests General Organization, Meeting Support Advertising Promotional Exhibit/Display Space
13
Eligible ProvidersFirewall requirementsAccreditation
Eligible AudiencesHCPs in training
Therapeutic Areas of Interest
Educational Format
Ineligible Grant Requests
Grant CriteriaGrant Criteria
cc
dd
ee
bb
aa
14
Grant Criteria: Eligible ProvidersGrant Criteria: Eligible Providersaa
Community Hospitals / Community Hospitals / Health SystemsHealth Systems
Community Hospitals / Community Hospitals / Health SystemsHealth Systems
Professional Societies and Professional Societies and AssociationsAssociations
Professional Societies and Professional Societies and AssociationsAssociations
Academic InstitutionsAcademic InstitutionsAcademic InstitutionsAcademic Institutions
Medical Education and Medical Education and Communication CompaniesCommunication Companies
Medical Education and Medical Education and Communication CompaniesCommunication Companies
OtherOtherOtherOther
15
Grant Criteria: Eligible Providers Grant Criteria: Eligible Providers Firewall RequirementsFirewall Requirements
Genentech prohibits providers* from both performing promotional activities and providing or accrediting independent medical education, unless an adequate firewall is in place
The following firewall policy criteria** must be satisfied by providers seeking funding from Genentech for an IME activity if the provider has a parent or sister company conducting or that could potentially conduct promotional activities for Genentech:
Separate employee/contractors
Separate legal entity
Separation of promotional/IME information and content
– Prohibition of sharing substantive information
– Physical separation of functions
– Information technology (IT) safeguards
Compliance training and audits
Monitoring of compliance policies
*Including parent or sister companies**List is not all-inclusive. Please see www.imed.gene.com for complete list of criteria
aa
16
Grant Criteria: Eligible ProvidersGrant Criteria: Eligible ProvidersAccreditationAccreditation
Preference will be given to activities and initiatives that are accredited for continuing healthcare professional education (CME/CE)
If the grant request is for $15,000 or greater and the proposed activity or initiative is accredited for continuing education, the accredited provider must request the grant funding from Genentech and is responsible for the activity or initiative
Payment may be designated to an identified third party
aa
17
Grant Criteria: Eligible Audiences*Grant Criteria: Eligible Audiences*
Physicians (Primarily specialist-
focused)
Physicians (Primarily specialist-
focused)
Nurses / Nurse Practitioners
Nurses / Nurse Practitioners
PharmacistsPharmacists
Physician AssistantsPhysician Assistants
bb
Medical Directors, Case Managers, Pharmacy
Directors
Medical Directors, Case Managers, Pharmacy
Directors Practice Managers Practice Managers
Other Allied HCPsOther Allied HCPs HCPs in Training (i.e., fellows and residents)
HCPs in Training (i.e., fellows and residents)
*Varies by therapeutic area
18
Grant Criteria: Eligible AudiencesGrant Criteria: Eligible AudiencesEducation Grants for HCPs in Training Education Grants for HCPs in Training
EligibilityEligibilityEligibilityEligibility
CriteriaCriteriaCriteriaCriteria
Funding may be permissible for HCPs in training (i.e., residents, fellows, others), in accordance with criteria set forth below for:
• Travel• Lodging• Other conference-related expenses
Funding may be permissible for HCPs in training (i.e., residents, fellows, others), in accordance with criteria set forth below for:
• Travel• Lodging• Other conference-related expenses
This is an exception to the general rule that there can be no funding for attendee travel and lodging.
Activities must be held in conjunction with an established activity, defined as the major educational, scientific, or policy making meeting of a national, regional, or specialty medical association, per the American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians From Industry.
HCPs in training must be selected through a formal selection process implemented by the academic or training institution submitting the grant request.
This is an exception to the general rule that there can be no funding for attendee travel and lodging.
Activities must be held in conjunction with an established activity, defined as the major educational, scientific, or policy making meeting of a national, regional, or specialty medical association, per the American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians From Industry.
HCPs in training must be selected through a formal selection process implemented by the academic or training institution submitting the grant request.
bb
19
Grant Criteria: Therapeutic Grant Criteria: Therapeutic Areas of InterestAreas of Interest
Allergic Disease Asthma
Oncology Breast Cancer Gastrointestinal Cancer General Oncology Glioma Non-Hodgkins Lymphoma Ovarian Cancer Renal Cancer Thoracic Cancer
Cardiovascular Acute Myocardial Infarction
Dermatology Psoriasis
Endocrinology Adult Growth Hormone Deficiency Disorders of Growth and
Development
Neurology Acute Ischemic Stroke Multiple Sclerosis Neuromyelitis Optica
Ophthalmology Macular Degeneration Vascular Permeability Disorders
Pulmonology Cystic Fibrosis Pulmonary Embolism
Rheumatology Arthritis Lupus
Thrombolytic Therapy Central Venous Device Restoration
General ImmunologyGeneral
Access to Therapy Education relevant to Payers,
Employers and Practice Managers
Priority for funding will be given to activities that focus on specific therapeutic areas of interest outlined by Genentech.
cc
20
Grant Criteria: Educational FormatGrant Criteria: Educational Format
Eligible activity formats include:
dd
LiveLiveSociety & Society &
Association Association Educational SupportEducational Support
Enduring MaterialEnduring Material
SymposiaSymposia
Multi-speaker Multi-speaker meetingsmeetings
Grand roundsGrand rounds
Web casts/online Web casts/online programsprograms
TeleconferencesTeleconferences
PrintPrint
CD ROMCD ROM
Web-based Web-based activitiesactivities
Educational Educational sessions at sessions at annual meetingannual meeting
Not Not generalgeneral support of the support of the overall meetingoverall meeting
21
Grant Criteria: Ineligible Grant RequestsGrant Criteria: Ineligible Grant Requests Grants for individuals or group practices
Retroactive support, including enduring materials
Enduring materials based on a previously completed live activity will not be considered
Travel, lodging, or registration expenses for non-faculty healthcare professionals to attend an educational activity (some limited exception for HCPs in training)
Capital or operating expenses
Stand-alone entertainment or social activities
Staff/professional development
Requests for exhibits or displays (providers may indicate there is an opportunity for exhibits or displays)
These may be requested from your field sales representative
Note: This is not an all-inclusive list
ee
22
Medical Education Grant ProcessMedical Education Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
23
To Get StartedTo Get Started
The IMED website provides information and resources to help providers apply for a grant, and includes:
Current therapeutic areas of interest
Eligibility criteria
Application process overview
Link to online application
FAQs, guidelines, and links to helpful resources
The IMED website provides information and resources to help providers apply for a grant, and includes:
Current therapeutic areas of interest
Eligibility criteria
Application process overview
Link to online application
FAQs, guidelines, and links to helpful resources
www.imed.gene.comwww.imed.gene.com
24
Applying for a GrantApplying for a Grant
Note: Online system will not allow for submission of grants less than 60 days prior to the planned start date of the activity.
Online Application:
Providers can register and apply for a grant directly on www.imed.gene.com.
– Providers should save username and password information for future grant applications
– Registration is to be renewed annually when notified by IMED
Confirmation:
Once a grant request is submitted, a confirmation e-mail will be sent to the provider.
– Users should check their e-mail and spam filters if confirmation is not received shortly
– If confirmation not received within 24 hrs, please contact IMED
Status:
The Grant Requestor Inbox will allow users to access and track their applications 24 hours a day, 7 days a week.
25
Compliance Commitment Compliance Commitment
By accepting commitment, grant requestors agree to comply with relevant society and association guidelines, including, but not limited to: ACCME, ACPE, CCRN, AAMC, ACCME, and PhRMA
Other terms of the Compliance Commitment: Does not constitute or represent a funding commitment by
Genentech for the specified educational program If grant request is approved, Genentech’s actual provision to you of
grant funds will constitute its sole funding commitment for the educational program
Indicates that neither the requestor nor the requestor’s organization is involved with any Genentech promotional activities, or that an appropriate firewall exists
Certifies that neither the requestor nor the requestor’s organization is on the OIG, FDA, or ACCME debarment or exclusion lists
26
What We Look ForWhat We Look For
Needs assessment and Needs assessment and learning objectiveslearning objectives
Appropriate activity Appropriate activity format/instructional design format/instructional design for the intended target for the intended target audienceaudience
Activity content aligned Activity content aligned with needs assessment with needs assessment and learning objectivesand learning objectives
Creative and interactive Creative and interactive conceptsconcepts
Fair-balanceFair-balance
Scientific rigorScientific rigor
Provider expertise in Provider expertise in activity’s therapeutic activity’s therapeutic areaarea
Overall quality of Overall quality of activity and activity and implementation planimplementation plan
ComplianceCompliance
Grant requests are reviewed using the following criteria:
27
Grant Requestor and 3Grant Requestor and 3rdrd Parties PartiesGrant Submission Grants ≥ $15,000: If the activity is accredited the accredited provider must submit the grant request Grants < $15,000: Grants may be submitted by a party other than the accredited provider
Designating Grant Payment Accredited providers may designate payment to a 3rd party logistics provider
Grant Notification and Letter of Agreement (LOA) Acceptance Currently, if the grant request is less than or equal to $15,000, the activity is accredited,
and the requestor is not the accredited provider: The accredited provider receives an email indicating that they have been named as
the accredited provider
If the grant is approved, the accredited provider receives a second email indicating that the grant has been approved
The accredited provider will be required to register on the GMA system and agree to the terms of the LOA along with the grant requestor
If a copy of the LOA is required, the LOA must be printed from the user’s web browser prior to selecting “Submit”
28
Required Information and Required Information and Documentation Documentation
Grant requests will require the following information/ documentation:
Signed IRS W9 form
Needs assessment
Activity learning objectives
Proposed agenda and/or content outline
Budget details for both the amount requested from Genentech AND the total budget for activity
Genentech Excel budget form required
Implementation plan*
* For activities with total budget ≥ $15,000
29
Needs AssessmentNeeds AssessmentA needs assessment is an analysis of the data supporting the need for a particular independent medical education activity.
Below are four examples of objective sources that could be used to validate need.
Data SourcesData SourcesData SourcesData Sources ExamplesExamplesExamplesExamples
1. Expert Data
Literature searches of peer-reviewed medical literature Practice guidelines and other published reports Advisory Board feedback Practitioner interactions
2. Market Research on Professional Needs
Focus panels Medical Communications feedback Survey(s) of the proposed target audience
3. Observed Data
National and regional data from national research institutes and healthcare organizations
Professional organizations (CDC, NIH, other) Reviews of past, present, and future planned activities
4. Past Activity Evaluation Summaries
30
Learning Objectives and AgendaLearning Objectives and Agenda
Clearly state what participant will learn from the activity
Clarify to grant reviewers the purpose of the activity
Be consistent with the needs assessment
Clarify the content within the activity and their duration
Show time devoted to education vs. meals and entertainment, if applicable
Be consistent with the learning objectives
Learning Objectives
Must…
The Agenda/Content Outline
Must…
1
2
3
1
2
3
•All grant applications must include the activity’s learning objectives along with a copy of the activity’s agenda and/or content outline.
31
Detailed Line-Item BudgetDetailed Line-Item Budget
Activity Development and Management Meeting Costs
Audience generation Meals during educational activity (please specify number of meals and cost per person per meal) Meeting room Materials Audio/visual support/equipment rental
Honoraria (select therapeutic area, specialty, role of recipient (faculty, moderator, etc), and indicate number of hours of work)
Travel (faculty and provider/staff only) Indicate all travel-related expenses separately
Hotel/Lodging (faculty and provider/staff only) Indicate number of hotel nights per faculty/staff member
Production Services Print/production (please provide detailed cost breakdown) Shipping Web-delivery expenses
Accreditation
Activity Development and Management Meeting Costs
Audience generation Meals during educational activity (please specify number of meals and cost per person per meal) Meeting room Materials Audio/visual support/equipment rental
Honoraria (select therapeutic area, specialty, role of recipient (faculty, moderator, etc), and indicate number of hours of work)
Travel (faculty and provider/staff only) Indicate all travel-related expenses separately
Hotel/Lodging (faculty and provider/staff only) Indicate number of hotel nights per faculty/staff member
Production Services Print/production (please provide detailed cost breakdown) Shipping Web-delivery expenses
Accreditation
Budget details for both the amount requested from Genentech AND the total budget for the activity will be requested.
The budget template must be downloaded from www.imed.gene.com and upload where indicated request.
Total amount and Genentech total should be entered in the grant application where indicated
32
Budget TemplateBudget Template
Introduction Definitions2 – Budget Enduring or Web1 – Budget Live1 – Budget Live
Activity Summary provides a highlight of the activity,
including activity type and cost
Grant Request Summary sums the total grant request (live
and enduring/web)
Genentech Cost and Total Cost are populated automatically from the
completed spreadsheet
33
Implementation Plan GuidelinesImplementation Plan Guidelines
Provide timeline and milestones
Explain how the activity will be executed
Provide the format for the activity (e.g., didactic, case-based, interactive)
Explain the educational method used, including the significance or uniqueness of the approach
Explain how fair-balance will be ensured in activity content
Indicate the roles and qualifications for all of the educational partners, including the accredited provider and any third parties
Explain how attendees will be encouraged to participate in the activity
Include specific examples of similar initiatives conducted in the past
Note: Guidance available on website and in application
Provide timeline and milestones
Explain how the activity will be executed
Provide the format for the activity (e.g., didactic, case-based, interactive)
Explain the educational method used, including the significance or uniqueness of the approach
Explain how fair-balance will be ensured in activity content
Indicate the roles and qualifications for all of the educational partners, including the accredited provider and any third parties
Explain how attendees will be encouraged to participate in the activity
Include specific examples of similar initiatives conducted in the past
Note: Guidance available on website and in application
Providers are required to submit an implementation plan for grant activities with budgets that are greater than or equal to $15,000.
34
Document Upload PageDocument Upload Page
The Document Upload Page will allow providers to upload the grant request’s supporting documents
The upload process is similar to uploading documents to an e-mail
The following documents are required to be uploaded with your grant request:
Signed IRS W9 form
Activity learning objectives
Agenda and/or content outline
Details of budget amount requested from Genentech AND the total budget for activity
Needs assessment* (level of detail required is contingent upon the total amount of the activity budget)
Implementation plan*
* For total activity budgets ≥ $15,000
35
Application ChecklistApplication Checklist
Time Key Supporting Documents
•The application checklist will help ensure complete applications are submitted to IMED.
Content Other
Request is submitted at least 60 days prior to activity’s start date or the date a decision is required
Duration of activity is appropriate to meet learning objectives
Time allocated for learning is not over-shadowed by time allocated for meals/entertainment, if applicable
Needs assessment is well-developed, current, and clearly identifies relevant educational gaps and is fully referenced
Learning objectives are clearly defined, realistic, and aligned with the needs assessment
Agenda and/or content outline is consistent with learning objectives and needs assessment
Activity is scientifically rigorous, balanced, and unbiased
Request is in alignment with areas of educational interest to Genentech
Proposed faculty is appropriate for the content and educational objectives
Budget is reasonable, cost-effective, and in line with fair market value
36
IME Grant ProcessIME Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
37
Decision and Letter of Agreement (LOA)Decision and Letter of Agreement (LOA)Timeline and RationaleTimeline and Rationale
Wk Wk 11
Wk Wk 22
Wk Wk 33
Wk Wk 44
Wk Wk 55
Wk Wk 66
Wk Wk 77
Wk 8
Wk 9
Wk 10
Wk 11
Wk 12
Initial Review
Medical Education Grants Manager (MEGM) and Grants Review Committee
Review
Decision/Approver Notification of LOA*
Check Sent
LOA Signoff by Provider**
Initial Review
• Application is reviewed for completeness of the application package• Providers will receive notification if additional information is required and will have 10 business
days to provide additional information to IMED• Providers will be reminded once of requests for additional information• If additional information is not received within the allotted time, the grant request may be denied• Process can take 1 to 2 weeks
MEGM and Grants Review
Committee Review
• Application is reviewed by MEGM, who reviews the request for all relevant criteria• Application is reviewed by Grant Review Committee and a funding decision is made• Process can take 2 to 6 weeks• Providers will be required to agree to the terms of the LOA prior to the start of the program; this
timeframe has been included as part of the 60-day turnaround commitment
We commit to a 60-day decision turnaround for all grant requests (turnaround time begins 60 days after complete grant application is received)
Notification of decision will occur within 60 days If the request is approved, payment may take up to 45-50 days after the date the approval was
communicated
* Assuming approval of grant**Assuming acceptance by provider
38
Reasons for Delay in Review ProcessReasons for Delay in Review Process
IRS W9 form not signed
Needs assessment not robust (lack of detail)
Questionable or unclear budget line items
Provider expertise and experience inquiries
Request for provider to complete an online Request for Information (RFI)
Lack of clarity on compliance-related items
Internal legal/compliance counsel required
The following issues often contribute to delays in the grant application review process:
39
IME Grant ProcessIME Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
40
Decision and LOA Timeline and RationaleDecision and LOA Timeline and Rationale
Wk 1
Wk 2
Wk 3
Wk 4
Wk 5
Wk 6
Wk 7
Wk Wk 88
Wk Wk 99
Wk Wk 1010
Wk Wk 1111
Wk Wk 1212
Initial Review
Medical Education Grants Manager (MEGM) and Grants Review Committee
Review
Decision/Approver Notification of LOA*
Check Sent
LOA Signoff by Provider**
Decision/ Approver
Notification of LOA
• If the grant is approved, an electronic LOA with the terms and conditions of the funding will be sent to all relevant parties for acceptance—once LOA is accepted by the parties, payment process is initiated
LOA Signoff by Provider
• LOA must be electronically signed by provider and third party (if applicable) prior to the start of the activity
Check Sent
• Check will be sent up to 45 days after LOA is accepted in GMA
We commit to a 60-day decision turnaround for all grant requests (turnaround time begins 60 days after complete grant application is received)
Notification of decision will occur within 60 days If the request is approved, payment may take up to 45-50 days after the date the approval was
communicated
* Assuming approval of grant**Assuming acceptance by provider
41
Grant DecisionGrant DecisionApplication ReviewApplication Review
ApprovalApproval DenialDenial
Provider requesting the grant is notified via e-mail that grant is approved, pending acceptance of the LOA
• A link to the LOA is included in the e-mail
• A hardcopy of the LOA can be obtained by printing from your browser prior to pressing “Submit”
LOAs must be approved prior to planned activity start date or grant may be denied
By signing the LOA you agree to:
• Be contacted by a third-party organization that posts educational programs to a disease education website; approval of grant request is not contingent on participation
• Acknowledge Genentech’s financial support and that of it’s partners, if applicable
• Provide activity implementation status updates and reconciliation of expenses and or operational components upon request
Provider requesting the grant is notified of denial via e-mail.
Common Reasons for Denial
1. Not an area of educational interest
2. Budget limitations
3. Not compliant with relevant laws, regulations, guidelines and/or Genentech policies
4. Quality of request
5. Submitted less than 60 days prior to planned activity start date
6. No response to request for additional information
7. Parties cannot agree to the terms of the LOA
Approval of LOAs by Third Parties in GMA
• Accrediting organizations and logistics providers (if payee) named in the grant request must agree to the terms in the LOA
- Accrediting organizations will be sent a link to approve the LOA online
- Providers will be responsible for obtaining signatures from logistics providers
42
IME Grant ProcessIME Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
43
Activity Execution Activity Execution
Optional activity assistance
Upon request, we can assist providers with the following:
1. Invitation distribution
2. Faculty recommendations
3. Clinical accuracy review
4. Genentech logo
Activity status reports
All requests must be submitted in writing to IMED only.
44
Invitation DistributionInvitation DistributionAll requests for invitation distribution must be submitted in writing to IMED only.
Genentech may only supplement the invitation process for the provider
Intent to request assistance must be indicated in original grant request
Formal written request must be submitted together with final invitation
Requests must be submitted and approved prior to activity start date
Approved invitation with Field Direction Memo will be distributed to field-based personnel via Genentech’s distribution channels
Providers should not distribute invitations to any field-based personnel directly
Provider will be responsible for shipping charges
Genentech review of invitations may take up to three weeks
In addition, allow one to two weeks for fulfillment and distribution to field-based personnel by the Genentech warehouse
Genentech recommends allowing three to four weeks for field distribution
Note: Not all requests for assistance will be fulfilled.
45
Faculty RecommendationsFaculty Recommendations
All requests must be submitted in writing to IMED only.
Genentech will provide at least three names for every one speaker/faculty/author requested
Providers are solely responsible for independently selecting faculty
Faculty should disclose any financial or other arrangements with supporting organizations
Note: Not all requests for assistance will be fulfilled.
46
Clinical Accuracy ReviewClinical Accuracy Review
Genentech will only review data that is pertinent to Genentech’s products
Genentech will not script or supply data, cases, draft text, or any other type of guidance in any of the slides and/or material prepared for the activity’s presentation
Please allow as much time as possible for review (minimum of two weeks)
Note: Not all requests for assistance will be fulfilled.
All requests must be submitted in writing to IMED only.
47
Use of Genentech LogoUse of Genentech LogoLogo License AgreementLogo License Agreement
The Genentech logo should NEVER be used without a signed logo license agreement in place.
Contact IMED to obtain permission to use the Genentech logo and to begin the logo license agreement process
The logo license agreement should be between Genentech and the accredited provider or other non-profit entity
48
•The Genentech logo can be used … on program materials and invitations for specific independent medical education events and enduring materials, by not-for-profit organizations only, if a logo license agreement is in place
•The Genentech logo should never be used … on a grant requestor’s external website, UNLESS it is in relation to a specific independent medical education activity, the entity requesting the logo is a non-profit organization, AND a logo license agreement is in place
The Genentech logo should NEVER be used without a signed logo license agreement in place.
Use of Genentech LogoUse of Genentech LogoGenentech Name or LogoGenentech Name or Logo
• If permission to use the Genentech logo is not granted … please recognize Genentech, using our name only, in accordance with the terms of the LOA.
49
Status ReportsStatus Reports
All status reports must be submitted to IMED only.
IMED requires status updates on implementation of larger activities (≥$250,000)
IMED may request status reports for any activity
IMED will provide a standard template with the request
Status report template is available on www.imed.gene.com under “Resources”
All status reports must be submitted on this template
Status reports must be submitted monthly
IMPORTANT: Please inform IMED of any changes to the execution of your activity in your status update
Date/timeline changes, format changes, etc.
51
Medical Education Grant ProcessMedical Education Grant Process
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
5 6
Grant Decision
Reconciliation
52
ReconciliationReconciliation IMED will require reports as part of its regular post-activity reconciliation process within
90 days of the activity end date
Note: Failure to reconcile may result in future grant requests not being considered Providers should not send IMED supplemental program evaluation reports for educational effectiveness at this time
Components of the Reconciliation
Current Components
1. Final activity report a. Type of event/activityb. Number and format of event(s) / component(s) in activityc. Estimated and actual number of participants by audience
type/specialtyd. Number of credit hours offered per activity, and total number of
credit hours issued2. Final agenda 3. Final invitation(s) / e-mail blasts4. Final handout materials/screenshots of Web activity5. Participant evaluation summary 6. Faculty evaluation summary (if available)
Future Components
All current components, plus:1. Financial reconciliation
a. Unused funds ≥ $250 to be returned2. Educational effectiveness
53
AgendaAgenda
• What is IMED?• What is the process for requesting
independent medical education grant funding from Genentech?
• What tools and resources What tools and resources are available to me?are available to me?
• Q & A
54
Contact InformationContact Information
Contact IMED by phone, fax, or online:
• Phone (866) 599-4363
Live Staff Hours of Operation: Monday - Friday 7:00 am – 5:00 pm PST
Majority of calls returned within 24 hours
Fax (866) 301-8891
Online E-mail: imed@gene.com
Further information and FAQs can be found at: www.imed.gene.com
www.grants.gene.com for a description of all grants and contributions that Genentech supports
55
Additional ResourcesAdditional ResourcesThe following websites provide information that will be helpful while completing a grant application:
Office of Inspector General (OIG) Guidelines (www.oig.hhs.gov)
Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support (www.accme.org)
Pharmaceutical Research and Manufacturers of American (PhRMA) Code on Interactions with Healthcare Professionals (www.phrma.org)
American Medical Association (AMA) Ethical Guidelines for Gifts to Physicians from Industry (www.ama-assn.org)
FDA Guidance on Industry-Supported Scientific and Educational Activities (www.fda.gov)
56
Grant Process RecapturedGrant Process Recaptured
1 2 3 4Grant
ApplicationGrant
EligibilityIMED Application
ReviewActivity
Execution
Providers must ensure that grant requests meet IMED criteria
Grant requests must be submitted via www.imed.gene.com
Requests must be submitted no less than 60 calendar days prior to the planned activity start date or the date the requestor requires a decision (whichever is earlier)
IMED will review requests to ensure that activities are compliant, fair-balanced, scientifically rigorous, and unbiased
The review process can take up to 60 calendar days
IMED provides limited optional activity assistance upon request
IMED may require providers to submit monthly status updates on activity execution
5 6
Grant Decision
Reconciliation
IMED will approve or deny the grant request
Providers will be notified of the grant decision via e-mail
IMED will require reconciliation reports within 90 days of the end date
57
AgendaAgenda
• What is IMED?• What is the process for requesting
independent medical education grant funding from Genentech?
• What tools and resources are available to me?
• Q & AQ & A
58
““Independent Medical Education Independent Medical Education Support from GenentechSupport from Genentech
Provider Training”Provider Training”
This session will be repeated live on September 10, 2007 at 4:00 PM ET, 3:00 PM CT, 2:00 PM MT, 1:00 PM PT September 10, 2007 at 4:00 PM ET, 3:00 PM CT, 2:00 PM MT, 1:00 PM PT
Gisela PaulsenDirector, Independent Medical Education Department
Trudi BloomMedical Education Grants Manager